Tag Archive for: Medical Tech

Emerging Technologies in Healthcare

Editor’s Note: In this blog, guest author Rahul Varshneya – President of Arkenea – breaks down emerging technologies that are changing the way healthcare is delivered in 2022.

Emerging Healthcare Technologies

It’s apparent that the pandemic has hastened the healthcare industry’s digitization. Working hand-in-hand with technology is the future of healthcare, and healthcare professionals must incorporate innovative healthcare technologies to stay in the spotlight in the coming years.
The Healthcare Technology Market is expected to be $390.7 billion by 2024. Therefore, many healthcare organizations that would not have been considered tech firms in the past have changed their focus to technology and its potential to transform how their products and services are delivered.

According to the HIMSS Future of Healthcare Report, over the next five years, 80 percent of healthcare providers aim to increase their investment in relevant technological solutions. Today, new technologies are being used in practically every healthcare institution to combat illness, develop new vaccinations, and treat patients to help them live healthier lives.

This article will help explore the four ways in which emerging technology is reshaping healthcare for the future:

1. Integrating Artificial Intelligence And Natural language processing For Seamless Experience

Many technical developments, including AI and NLP, are increasingly being lauded for their ability to alter the healthcare industry.

From enhancing clinical data by mapping data elements in unstructured text to structured fields in Electronic Health Records to converting data from machine-readable or different formats into natural language for reporting and training/education purposes, AI, and NLP have it all covered.

The high-level use case for artificial intelligence in healthcare is aiding in the analysis of enormous amounts of unstructured data.

More recently, Google’s DeepMind created an A.I. for breast cancer analysis. On pre-selected data sets, the algorithm outscored all human radiologists by 11.5 percent on average in detecting breast cancer. Avive Solutions developed Avive AED that utilizes AI to improve survival rates for cardiac arrest.

Given the abundance of patient input, healthcare facilities must begin investing in and deploying NLP-powered patient feedback management solutions to secure and ensure patient loyalty.

A 2018 study evaluated radiology reports for pulmonary embolism and postoperative venous thromboembolism and discovered that unorganized data analysis established 50% more cases than structured information alone.

AI and NLP definitely be the driving force in the future for better clinical decision support and patient health outcomes.

Related: Medical Device Startup, Proprio, Chooses Jama Connect® to Drive Innovation

2. The Power of Augmented Reality & Virtual Reality in Healthcare

Patients can find hospitals to be a stressful setting, making it extremely challenging to keep up with anxiety levels and heart rates while undergoing treatment. VR can present itself as an appealing possibility for assisting patients in relaxing and suffering less in such painful scenarios.

A recent Harvard Business Review study showed that VR-trained surgeons exhibited a 230 percent increase in overall performance as compared to their traditionally trained peers. Virtual and augmented reality solutions, which are continually expanding, have had a tremendous impact on healthcare technology

A 2016 report says: “Patients have benefited from VR technology, which has shown to be effective in pain management. Women are being given virtual reality headsets to help them imagine calm places while childbirth.”

Whether it’s using VR to give an exciting experience for patients to virtually visit a health institution or using VR to allow the patient to deal with pain, there is much to be intrigued about.
For the past decade, advancements that were inconceivable are now being realized. In 2022, the number of AR applications in healthcare will also increase.

AccuVein has come up with a real-world problem-solving technique using augmented reality. The use of AR here makes it much easier for clinicians to locate veins when administering injections by sensing the heat signature of the blood flow and outlining it on the patient’s arm. Using the AccuVein vein finder has been found to improve the likelihood of first stick success by 3.5 times and to reduce the need to call for assistance by 45%.

Implementing such emerging technology allows healthcare practitioners unfettered access to activities that are not currently available, as well as allowing individuals to regain their overall health and mental well-being.

3. Role Of IoMT And Wearables In Healthcare

Without a doubt, the Internet of Medical Things (IoMT) is ushering in a new era of change in the healthcare industry by rethinking the interplay between people and devices in the delivery of healthcare solutions.

The global IoMT market was worth $44.5 billion in 2018, and by 2026, it is predicted to be worth $254.2 billion. Investments in IoMT are already on the upswing, and the healthcare technology trend is expected to grow in the future years.

Certain remote areas in the US cannot afford to have full-time hospitals. IoMT devices bring regular consultations into people’s homes, which is especially important for patients with limited mobility. Portable point-of-care devices are being used to run regular tests now and share the results remotely with a doctor.

Devices that are part of the Internet of Medical Things are now solving problems that the healthcare sector had to deal with in 2020.

For example, many patients tend to miss their medications and this needs to be monitored. This issue takes on added urgency since studies demonstrate that only half of the chronic disease medications are used as prescribed.

To address this concern digital blood pressure cuffs (smart pills equipped with edible sensors) are being used to deliver a continuous stream of blood pressure and pulse data to a doctor that will alert their patients if they are taking their medications as prescribed.

In addition, the development of wearable apps in healthcare has made health monitoring easier than in the past. Wearables such as watches, bands, and other accessories have made it easier to track health metrics.

DARPA (Defense Advanced Research Projects Agency) has also been working on various wearable computers that have helped patients with epilepsy and strokes by stimulating or deactivating portions of the brain. This technology helps amputated patients regulate the motions of their prostheses by interfacing with their brain system.

Thus, wide adoption of IoMT devices would be the easiest to predict among the health tech trends soon.

4. Made Easy By Personalized Mobile Apps And Chatbots

Consumers are accustomed to the seamless experience that a mobile app provides. The healthcare sector is not an exception. Numerous patient scenarios can be delivered shortly by a potent native mobile application.

From soliciting physician consultations, uploading a patient’s medical record, and receiving lab tests via a mobile app, health organizations can certainly develop useful digital technology that is ideal for today’s patients.

A customized mobile app with integrated EHR/EMR systems could become the single most essential point of interaction between healthcare practitioners and patients.

One such scenario was when the SharpQuest team created My Care Central, a patient-facing mobile app that allows users to contact clinicians and nurses, view appointments, prescriptions, and much more.

The results concluded improved care processes yielding an average 4.9/5 patient rating, improved clinician satisfaction with easier workflow and positive feedback, and reduced costs from printed materials

Providing a tailored experience is crucial in healthcare, and a chatbot adds another touchpoint that customers value. The way healthcare is probably offered will alter as the number of chatbots grows at such a rapid rate.

With the potential for improvement in patient pathways, there is plenty of scope for improvements in patient routes, medication management, and assistance in emergency circumstances.

Healthily app has implemented this technique to provide information about different diseases’ symptoms, assessments of overall health, and tracks patient progress.

Furthermore, chatbots can be used to provide mental health help by bringing in cognitive behavioral therapy (CBT) to patients suffering from depression or post-traumatic stress disorder (PTSD). Woebot, (launched in 2018) is among those successful chatbots that provide CBT, mindfulness, and Dialectical Behavior Therapy (CBT).

Choices are limitless for chatbots, from care management service to potential diagnosis of mild conditions there’s plenty to be enthused about within the technology.

Related: An Interview with Award-Winning Medical Device Risk Management Educator and Author Bijan Elahi

Final Thoughts

Today’s healthcare industry has profited immensely from technological advancements. Emerging technologies are helping to produce new, better approaches while also lowering expenses. Although some technologies are yet to be completely explored, they have already caused a remarkable shift in the industry.

The arrival of new technologies such as artificial intelligence (AI), natural language processing (NLP), augmented reality (AR), virtual reality (VR), and chatbots are radically transforming the landscape and ushering in a new era in healthcare. In this industry, the purpose of digitization is to improve healthcare quality while reducing the physician burden.

These ‘patient first’ technologies are clearing the way for new sectors of medical science applications, enabling patients to live longer while also contributing to research and innovation.


Solution components in the Jama Connect for Medical Device Development solution help teams reduce time-to-value, provide guidance around customer-specific needs, and drive adoption.

We wanted the solution to offer a collection of training and documentation components that aligns to industry regulations so product development teams could get ramped up quickly.

The result: an out-of-the-box configuration of Jama Connect, an accompanying Procedure Guide, and Jama Professional Services. It’s a solution designed to reduce time-to-value, account for and provide tailored guidance around customer-specific needs, and drive adoption through tailored training and on-going support. Let’s take a look at the components and see how they help achieve those goals.

Note: Now that our medical device blog series is concluded, you can go back and read the series intro, Part I, and Part III.

Procedure and Configuration guide: Jama Connect, clearly aligned with regulations.

The Jama Connect for Medical Device Development Procedure and Configuration Guide provides detailed alignment between these regulations and standards and the out of the box configuration and recommended use of Jama Connect:

  •        ISO 13485:2016
  •        ISO 14971:2019
  •        21 CFR 820.30

The scope and processes described in the guide are clearly identified and justified.

An important point to note: we identified the Jama Connect capabilities that align with the most relevant design control requirements needs. Then we targeted those needs, and optimized Jama Connect to meet them exactly.

The regulations and standards establish the design control requirements and provide some guidance, but they are not prescriptive in terms of tools or techniques. The procedure and configuration guide explains in detail how to bring in best practices from systems thinking, supported by use of Jama Connect, while still complying with design control requirements. .

Teams building complex medical devices will benefit from this systems-thinking approach and the way the Procedure and Configuration Guide builds these layers into the configuration. The principles and guidance provided by the Systems Engineering Body of Knowledge (SEBoK) and the recommended use of Jama Connect will bring clarity around product definition and verification activities.

medical device requirements

Out-of-the-box-configuration: Start with standardized guidance and build from there.

The out-of-the-box configuration provides a recommended project template that allows customers to get up and running quickly.  It also serves as a starting point for customer-specific discovery and configuration. Each aspect of the configuration aligns with the applicable regulations and standard through detailed process activities and tasks described in the procedure guide

The configuration also provides Export Templates you can use to generate documentation from Jama Connect for transport into your Quality Management System (QMS), typically used to house all Design History Files for sign-off and audit.

 

On-site consulting and training services to align your teams quickly.
Jama Software’s Professional Services team works to help customers reach several goals:

  • Build adoption, decrease time-to-value, and maintain ease of use.  
  • Focus on process alignment, people readiness, and best practices for configuration and use.   
  • Take advantage of the recommendations and guidance described in the Procedure and Configuration Guide and built into the out of the box configuration.    
  • Provide end-user training tailored to the customer’s use and configuration of Jama Connect . 


Taken as a whole, the Jama Connect for Medical Device Development solution provides the guidance, justification and a starting framework that not only answers “what” Medical Device manufacturers should do when deploying Jama Connect, but also “how” and “why” they should do it.    

In upcoming blogs in this series, we’ll explore specific aspects of the Procedure and Configuration Guide and the out of the box configuration of Jama Connect. We’ll also look at how the solution components described in this blog are applied in practice.    


Download a Solution Brief for an overview that explains all the ways Jama Connect for Medical Device Development can help your teams manage shifting complexities and maintain product quality and safety.

                      

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Today, Jama Software announces a new solution: Jama Connect for Medical Device Development. The launch feels especially relevant right now. Over the next few weeks I’ll share details about it with you here in the blog. I’m going to talk about:

  • The solution background: why it came to be and what it does.
  • Solution Components
  • Design Inputs
  • Connect Design Inputs, Design Outputs and Verification
  • Traceability

We’re pleased we’ll be able to help medical device manufacturers support design control activities in the highly regulated product delivery environment and contribute to their goals of quality and safety.

Note: Now that our medical device blog series is concluded, you can go back and read the series intro, Part II, and Part III.

Streamlined and focused configuration for medical device development.

The idea for the Jama Connect for Medical Device Development solution grew from the need to align quickly to medical device regulations and standards within a requirements platform.

The highly configurable Jama Connect platform allows customers to align the system with specific requirements, risk, and test process needs. If there’s a particular type of information to capture or a specific list of values that would support the overarching process, customers can configure Jama Connect to align and support it.

However, a highly configurable system introduces challenges. During deployments, you have to ask, “Yes, we can do anything, but what should we do?” Think of a highly configurable system as a blank canvas. You can find yourself staring, directionless, and not know where to begin.

That matters when there’s an entire team staring at the blank canvas. It wastes resources and impacts the time it takes to gain value from the system. In the end, the result can be a misaligned, frustrating deployment and low user adoption.

An out-of-box configuration that brings immediate benefits.

The challenge described above is precisely why Jama Software created the Jama Connect for Medical Device Development solution. We wanted to help Medical Device manufacturers who deploy Jama Connect in a highly regulated environment:

  • Increase the value of Jama Connect, and decrease the time to realize that value.
  • Access a recommended, out-of-the-box configuration.
  • Maintain alignment with design control regulations and standards that Jama Connect is best suited to address.

With the Jama Connect for Medical Device Development solution, deployments no longer start with a blank canvas. Instead, the picture comes out of the box, justified and properly aligned with medical device regulations and standards. Configuration is still possible and valuable, but streamlined and focused.

Customers can hold an out-of-the-box configuration and recommended guidance against their operating procedures to:

  • Identify and justify unique, customer-specific needs.  
  • Determine the best approach to address those needs.  
  • Incorporate customer-specific nuances for tighter alignment to the company operating procedures.  

In next week’s blog post, we’ll explore solution components in more detail.


Discover more details and watch a demo of the new Jama Connect for Medical Device Development solution here.

 

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jama connect for medical device development

Today, Jama Software, introduced Jama Connect for Medical Device Development, a new solution designed to help engineering teams better manage device requirements, risk and design control all on one powerful platform. The newest release makes regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment with no reduction in quality.

Consistent product quality and safety proves to be the top challenge for innovators throughout the medical device development lifecycle. Constantly evolving regulations and the new complexities presented by connected devices makes management of these shifting complexities difficult. Our teams have been hard at work to bring this solution to fruition and help medical device developers simplify and accelerate the development lifecycle. This single platform can help accelerate innovation, maintain consistency and high product quality, and manage ever-changing complex regulations in medical device development.

“Developers are balancing increased regulatory requirements with device development costs that lead to challenges across the production lifecycle,” said Josh Turpen, Chief Product Officer at Jama Software. “We’re excited to introduce our new solution designed specifically for medical device companies which will help ease the development process from the start. Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving product teams from the cumbersome and often frustrating process of filing paperwork.”

Note: Now that our medical device blog series is concluded, you can go back and read Part I, Part II, and Part III.

Jama Connect for Medical Device Development can help teams:

• Easily demonstrate traceability
• Manage risk analysis
• Maintain audit trails and export data
• Improve product development with reuse and baseline management
• Streamline compliant reviews and approvals
• Manage design verification and validation

Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training and documentation aligned to industry regulations ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019, while applying a proven Systems Engineering approach to product development. When you purchase Jama Connect for Medical Device Development, our consultants partner with you to adapt the solution to fit your product delivery process and build adoption of Jama Connect within your organization. Contact us to learn more.

About Jama Software

Jama Software provides the leading platform for requirements, risk and test management. With Jama Connect for Medical Device Development, teams building complex products, systems and software improve cycle times, increase quality, reduce rework and minimize effort proving compliance. Representing the forefront of modern development, Jama’s growing customer base
of more than 600 organizations includes Boston Scientific, Johnson & Johnson, Abbott, and Merck.

Visit jamasoftware.com/solutions/medical-devices to learn more about Jama Software for Medical Device Development.

 

 

Despite ongoing concerns about cybersecurity, the medical device landscape has seen some amazing advances even just this year.

Putting the End User in Control

End users, consumers, and patients are finding themselves with more knowledge about — and control over — their health than ever before. And that’s thanks, in part, to recent advancements in medical tech and, wearables, in particular.

In 2018, Apple introduced the first direct-to-consumer EKG wearable “cleared” by the FDA when it rolled out the EKG and irregular heartbeat features on its Series 4 Apple Watch. The watch has been classified as a Class II medical device, and a recent Standford University study revealed it can help detect atrial fibrillation — a type of irregular heart rhythm, which is the leading cause of stroke and hospitalization in the U.S.

Combined with other medical tech advancements like Bluetooth-enabled “smart” inhalers for asthma and COPD sufferers and wearable blood pressure monitors, the medical device industry continues to trend toward giving patients better control and management over their own health. Between 2014 and 2018, consumer use of wearables jumped from 9% to 33%. There are currently almost 200 clinical trials involving medical tech wearables in progress.

The impact of such fast-moving technology is still being measured, and, among other things, it’s making some question if wearables might actually decentralize medical care by making frequent visits to the doctor’s office less necessary.

Read our eBook to learn more about risk management for Class II and Class III medical device development.

In the Field

Medical tech and medical devices continue to improve patient care in clinical settings as well.

Artificial intelligence company care.ai is working with Google to develop a “Self-Aware Room” for hospitals. This technology would monitor patient conditions and send notifications to staff to keep them apprised of patient conditions. The technology could help clinicians better manage patient safety and health by predicting things such as preventable falls, pressure ulcers, and infectious diseases that would compromise patient health.

The partnership is part of an overall trend toward edge computing in hospital settings. Though edge computing doesn’t solve all cybersecurity challenges by any means, the trend does bring computing closer to the data source — in this case, the patient — which can help to mitigate some cybersecurity challenges.

AI and augmented reality technologies are also changing operating rooms. One recent report suggests that as many as 45% of operating rooms will be integrated within the next four years. The intelligent technologies will result in less invasive surgeries and improved patient outcomes.

Microsoft and Phillips have also partnered to develop augmented reality technology for surgery. The technology would transfer live imaging and other sources of information into a 3D holographic environment that the surgeon could control.

Alex Kipman, technical fellow, AI and mixed reality at Microsoft, notes that “[m]ixed reality holds great potential in healthcare, and our collaboration with Philips shows how that potential is already beginning to be realized.”

Learn more about how Jama Connect™ helps medical device developers streamline and speed up the development process while reducing risk.

Cybersecurity Concerns

Of continuing concern for medical device manufacturers and their partners are cybersecurity threats.

The FDA recently issued a safety communication concerning the URGENT/11 security threats. These vulnerabilities were first identified in July, and they affect several operating systems used in medical tech and industrial devices.

Suzanne Schwartz, M.D., MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, noted that the FDA was not aware of any patient harm resulting from the URGENT/11 vulnerabilities. However, she noted that “the risk of patient harm if such a vulnerability were left unaddressed could be significant.”

The communication highlights the ongoing challenges of not only addressing current vulnerabilities and cybersecurity threats, but also integrating protections into medical devices currently under development. Staying one step ahead of remote attackers is always a challenge for developers in any industry, but in the medical tech realm, patient health is a very present concern. Security vulnerabilities can put patient health and safety at risk.

The FDA also recently introduced a new, voluntary program for medical device and device-led combination products. Called the Safer Technologies Program for Medical Devices, the program is designed to help expedite development, assessment, and review of certain medical devices that are not eligible for the Breakthrough Devices Program. Draft guidance for the Safer Technologies Program is available online; the commenting period ends November 18, 2019.

Learn more about recent pending updates to the FDA’s cybersecurity for premarket submissions in this blog post.

Potential for Collaboration

Though the market entry of such tech giants as Amazon and Apple can pose challenges for legacy medical device manufacturers, the Microsoft/Phillips and care.ai/Google collaborations suggest a development that could benefit all parties.

While tech giants don’t have a long history of navigating the FDA approval process, they have been grappling with cybersecurity issues for some time. Medical device manufacturers and tech giants would be wise to combine their strengths and expertise to continue to combat cybersecurity threats while bringing new medical devices to market and improving patient care.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.